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Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 Diabetes
Plain-language guide to NCT00184574: phase 3 randomized trial of Insulin Aspart, 603 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00184574
- Phase
- phase 3
- Status
- completed
- Start
- 2005-04
- Completion (planned or actual)
- 2006-03
- Participants
- 603 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Insulin Aspart.
This trial is conducted in Europe.
This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different premixed insulin analogues given in combination with an oral anti-diabetic drug.
The registry classes the interventions as drug.
Who Took Part
The registry lists 603 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 2 diabetes. Currently treated with insulin. Currently treated with Metformin.
The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: body mass index (bmi) \< 25.0 or \> 40.0 kg/m2; metformin contraindications according to local practice; TZDs within 6 months prior to randomisation.
How the Study Was Run
It was run as a randomized, single-group and open-label study.
Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.
Being open-label, the Insulin Aspart study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2005-04 with completion listed for 2006-03.
It ran at 108 sites in Germany (15), Italy (12), France (11), Spain (10), United Kingdom (9) and Netherlands (6).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): HbA1c (time frame: after 36 weeks).
It also tracked 3 secondary outcomes, for example 8-point plasma glucose profiles, Safety variables and Other glycemic variables.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Aspart in 603 people.
With 603 participants it is a large trial for this field.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin Aspart compound page, all human trials.
Our Notes on the Compound
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.